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NMT Medical Announces Preliminary Results of CLOSURE I PFO/Stroke Trial
17.06.2010 21:23
http://www.finanznachrichten.de/nachrichten-2010-06/17186432-nmt-medical-announces-preliminary-results-of-closure-i-pfo-stroke-trial-004.htm
Primary End-point Not Achieved;
Trial Demonstrates Slight Benefit Over Current Best Medical Therapy
NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced that it has received preliminary results for CLOSURE I, its patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the U.S. CLOSURE I is the first fully enrolled, randomized clinical trial to evaluate the effectiveness of PFO treatment in preventing recurrent strokes and TIAs. Analysis of the data for CLOSURE I commenced in April 2010.
The preliminary results of CLOSURE I data analysis indicate that the trial did not achieve its primary endpoint: to demonstrate that treatment by device closure with the STARFlex® technology is superior to the current best medical therapy for preventing recurrent strokes and TIAs. However, the preliminary results indicate that closure with STARFlex® provided a small, but not statistically significant, benefit over current best medical therapy.
The trial's preliminary results indicate that the safety profile of the STARFlex® device had a low rate of complications, similar to that of current best medical therapy. In addition, there was a very low rate of thrombus formation. Closure rates in the trial were 86.5%, which is consistent with NMT's previously reported results for the STARFlex® implant, and in line with other transcatheter closure devices.
NMT President and Chief Executive Officer Frank Martin said, "Although we are disappointed that we did not meet the primary endpoint, we are currently in discussions with the U.S. Food and Drug Administration (FDA) to evaluate our possible next steps relating to the stroke/TIA indication. In addition, we are working with our clinical investigators, contract research organization, and the CLOSURE I Executive Committee to analyze the full trial data set to help us better understand and evaluate our clinical and regulatory options. We will update our stakeholders on our strategy going forward once we have completed some additional discussions with all parties. It is anticipated that full data results will be discussed at the American Heart Association meeting in November 2010."
"The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," Martin said. "NMT remains committed to addressing structural heart disease through minimally invasive, catheter-based procedures. We are continuing to develop the next generation of bioabsorbable implants, including our BioTREK™ device. In addition, we should note that the results of CLOSURE I have no impact on the status of our current FDA and CE Mark approvals for ventricular septal defect (VSD) and atrial level shunt patients."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 33,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
For more information about NMT Medical, please visit www.nmtmedical.com .
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements - including statements regarding the timing, cost, clinical status, and outcome of the Company's CLOSURE I trial, its ongoing clinical trials and development programs, expansion of the Company's cardiovascular business and market opportunities, including stroke, TIA, migraine and any other new applications for the Company's technology or products, and regulatory approvals for the Company's products in the United States and abroad - involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company's ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2009 and subsequent filings with the U.S. Securities and Exchange Commission.
Contacts:
NMT Medical, Inc.
Richard E. Davis, 617-737-0930
Chief Operating Officer
red@nmtmedical.com
© 2010 Business Wire
NewCardio Implements Management Succession as Company Shifts from Development to Commercialization
Date : 06/16/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43251337&symbol=NWCI
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, today announced that Vincent W. Renz, the Company's President and Chief Operating Officer, has been promoted to Chief Executive Officer and elected to NewCardio's Board of Directors as part of a planned succession designed to facilitate the Company's continuing move to a commercial enterprise that will bring the platform technology and related solutions to market and accelerate revenue growth. Dr. Branislav Vajdic, has resigned as Chief Executive Officer, but will remain on the Company's board of directors as Vice Chairman. Additionally, Dr. Vajdic now will focus his efforts, full time, in the areas of technology and product development, serving as a Special Fellow, reporting to the Chairman of the Board.
Mr. Renz joined NewCardio as President and COO in August of 2008, bringing to the Company more than 26 years of experience in the information technology industry, specifically in the development and commercialization of technology products and services. He joined NewCardio from ClinPhone, previously the world's leading Clinical Technology Organization which was acquired by PAREXEL International Corporation, a leading global biopharmaceutical services organization. At ClinPhone, Mr. Renz served as Chief Operating Officer. Previously, he worked for eResearch Technology, Inc. as the Executive Vice President and Chief Technology Officer and played a key role in building eResearch Technology's clinical technology business. Mr. Renz was also instrumental in developing the global business development and client services infrastructure to support the company's rapid growth and profitability. Mr. Renz earned an M.B.A. in Management Information Systems from Indiana University and a B.B.A. in Finance from the University of Notre Dame.
"We have made tremendous progress in our efforts to develop and commercialize our platform technology, and the market reaction to QTinno™ and the early attention on the CardioBip™, has validated our confidence in the underlying platform technology," commented Mark W. Kroll, PhD, FACC, FHRS, NewCardio's Chairman. "We are deeply gratified for the vision of our founder, Dr. Branislav Vajdic, and thank him for his efforts to bring us to this point. Our efforts to transition from product development and increasingly focus on commercialization of our platform technology and the related solutions will be enhanced by this planned succession that will have Mr. Renz leading our management team going forward. Vinnie Renz has built and managed our operations team and driven our commercialization process, which has resulted in widespread industry acceptance. He is the ideal person to assume the strategic and tactical leadership of the Company on a day-to-day basis. We are also gratified that Branislav will continue to assist the Company with strategic initiatives in the future and be available to facilitate a smooth transition."
Mr. Renz added, "Under Dr. Vajdic's leadership, we have developed a powerful and comprehensive platform technology which promises to bring improved accuracy and increased diagnostic value to the ECG, the most widely used test in cardiology. We stand at the beginning of a significant shift in drug development, and QTinno is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development. To date, we have signed Master Services Agreements with 3 of the top 5 CROs in the industry, and forged relationships with other clinical trial service providers and drug sponsors. We will continue to drive the applications of our 3D technology including CardioBip™ and Cardio3KG™. Looking forward, CardioBip can radically improve the remote cardiac monitoring process as the first non-invasive, remote, wireless device which delivers accurate 12-lead ECG results. Our Cardio3KG solution is expected to significantly improve the diagnosis of cardiac events in an urgent care setting, saving lives and improving clinical outcomes. I am excited to receive the baton from Branislav, and build upon his vision as we commercialize these three solutions and grow the underlying platform technology."
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
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SOURCE NewCardio, Inc.
NexMed Announces Pre-Clinical Results Showing That Its Proprietary Calcipotriene Betamethasone Psoriasis Formulation is Bioeq...
Date : 06/15/2010 @ 9:20AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=43234364
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced results from a pre-clinical study showing that calcipotriene 0.005% and betamethasone dipropionate 0.064%, when formulated with NexACT®, results in a topical treatment which shows bioequivalecy in efficacy to Talconex®, one of the leading topical treatments marketed for patients with mild to moderate psoriasis.
NexMed conducted two pre-clinical studies on its NexACT-based topical psoriasis treatment. The first efficacy study using a cadaver skin model showed that the NexACT-based formulation of the two active drugs delivered the same level of drugs (measured in ug/cm2/hour) as compared to the commercial Talconex® product. In a second efficacy study, using the DNFB induced allergic contact dermatitis (ACD) pig model, results showed that the NexACT-based formulation significantly lowered the clinical inflammation and erythema score in sick animals. The DNFB induced ACD pig model is the standard pre-clinical model for testing efficacy of calcipotriene-based drugs for psoriasis treatments under development.
Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, “We have a competitive psoriasis treatment under development. Our NexACT-based formulation is novel and does not infringe on the marketed topical treatments. Our data, though early stage, shows bioequivalency to Talconex®, and further supports the versatility of the NexACT technology and its applicability to a broad range of disease states. We look forward to commencing partnering discussions for continued development of this product candidate.”
About Psoriasis
Psoriasis is a chronic autoimmune disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. There are five types of psoriasis: plaque, guttate, inverse, pustular and erythrodermic. The most common form, plaque psoriasis, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale. Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes, heart disease and depression. According to the National Institutes of Health, as many as 7.5 million Americans and 125 million people worldwide, have psoriasis.
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT® drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company including but not limited to its ability to replicate pre-clinical results in human clinical trials, whether its product candidates infringe on third party rights, and whether the it can successfully partner product candidates.
San West Inc. and Buggy World Named Exclusive Retailer of BMS Scooters and Dune Buggies for Eastern San Diego County
Date : 06/15/2010 @ 8:30AM
Source : MarketWire
Stock : San West Inc. (SNWT)
http://ih.advfn.com/p.php?pid=nmona&article=43233120
SAN DIEGO, CA -- (Marketwire)
06/15/10
San West Inc. (OTCBB: SNWT) an emerging leader in the off-road vehicle (ORV) industry, operator of the industry leading ORV portal, www.CountyImports.com, and Buggy World retailers, today announced that it has been named the exclusive retail distributor for BMS Scooters and Dune Buggies for the Eastern San Diego County area.
BMS is an innovative manufacturer of popular, high-quality off-road vehicles and scooters at competitive prices. The Los Angeles-based company manufactures and imports a complete line of scooters, dune buggies, ATVs and UTVs. BMS produces scooters ranging from 50cc to 250cc in size, and dune buggies which range from 250cc to 1,100cc.
"We are excited to add the BMS line of scooters
and dune buggies to our retail showrooms on an exclusive basis, beginning today," commented San West Inc. CEO Frank Drechsler. "These popular products include exciting features, such as aluminum floorboards and chrome accent pieces, and we are confident the BMS line will attract new customers. Our strong reputation for customer service, excellent reputation and growing regional presence convinced BMS that we were the ideal retail partner to distribute this popular line of products in the eastern San Diego County region. We are gratified with their confidence and look forward to a long and mutually profitable relationship."
The Company's Internet portal, www.CountyImports.com, has carried BMS products since 2005.
About San West Inc.
San West is an emerging leader in the off-road vehicle (ORV) industry and operator of the industry leading ORV portal, www.CountyImports.com. The Company's web properties have emerged as the established home for all facets of the ORV industry, including off-road buggies, scooters, ATVs, parts and accessories. San West's retail store locations in Southern California specialize in the design, manufacture, sales and repairs off-road buggies. Additionally, the retail and online stores provide aftermarket performance products and accessories for off-road buggies and other ORVs. Buggy repair services are sold and fulfilled at the Santee, California retail location. For further information about San West Inc. visit www.CountyImports.com, www.CountyImportparts.com, www.BuggyNation.com and www.SanWestInc.com.
Certain statements contained herein are "forward-looking" statements (as defined -- Private Securities Litigation Reform Act of 1995). SNWT cautions that the statements made in this press release constitute forward-looking statements and no guarantees of future performance and actual results or developments may differ materially from projections in forward-looking statements. Forward-looking statements are based on estimates and opinions of management at time the statements are made.
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Registered in England and Wales No. 3248123
NewCardio Selected to Make Presentations at 32nd Annual International Conference of the IEEE Engineering in Medicine & Biology Society
Date : 06/14/2010 @ 9:42AM
Source : Business Wire
Stock : NewCardio, Inc. (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43216294&symbol=NWCI
NewCardio, Inc., (OTC BB: NWCI) a cardiac diagnostic technology provider, announced today that two of its recent medical
and technical submissions have been accepted for presentation at the 32nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society conference. The two papers: “Wireless Transmission of Reconstructed 12-Lead ECGs in the Remote Monitoring of Atrial Fibrillation” and “Wireless Remote Monitoring of Myocardial Ischemia Using Reconstructed 12-Lead ECGs” will be presented during the conference to be held August 31st through September 4th, 2010, in Buenos Aires, Argentina.
NewCardio scientists and their academic medical collaborators will present data from two full clinical studies showing that CardioBip™ accurately captured, wirelessly transmitted, and reconstructed full 12-lead ECG data from two distinct patient groups: (1) patients with coronary artery disease (CAD) with significant risk for myocardial infarction, i.e. a heart attack, and (2) patients with atrial fibrillation (AF), who are at significant risk for stroke because of recurrent bouts of AF. CardioBip is a unique, hand held device that provides for accurate and timely diagnoses of acute cardiac events, and facilitates immediate intervention in life-threatening situations – even when the patient is far removed from a medical care center. Images of the CardioBip are available at www.newcardio.com/products-cardio-bip.php.
"This now marks the second very prestigious medical conference that has accepted two of our papers for presentation this year. The acceptance of these submissions reflects the growing interest in telemedicine and the recognition that our science and technology solutions are gaining acceptance in the industry because of their quality and innovative nature, and because they meet important and previously underserved needs,” stated NewCardio CEO Branislav Vajdic, PhD.
Medical experts increasingly recognize the need for long-term outpatient monitoring of such patients, and the Company believes the clinical study results that will be presented at the IEEE Conference indicate that CardioBip is well-suited to fill this unmet medical need.
The conference program will consist of plenary lectures, symposia, workshops and invited sessions of the latest significant findings and developments in all the major fields of biomedical engineering. Submitted papers will be peer reviewed. Accepted high quality papers will be presented in oral and poster sessions, will appear in the Conference Proceedings and will be indexed in PubMed/MEDLINE.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
Cardium Announces Dominique Dawes, Olympic Champion, as Web-Based Spokesperson for New MedPodium Podiatry-Focused Advanced Skin Care Product Line.
Date : 06/14/2010 @ 9:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&article=43215434&symbol=CXM
Cardium Therapeutics (NYSE Amex: CXM) today announced Dominique Dawes, an Olympic champion, as the official web-based spokesperson for the Company's MedPodium podiatry-focused advanced skin care product line.
(Photo: http://www.newscom.com/cgi-bin/prnh/20100614/LA20014)
(Photo: http://photos.prnewswire.com/prnh/20100614/LA20014)
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
Dominique Dawes is an Olympic gymnast who competed in three Olympic Games, won three medals and has a permanent place in the U.S. Olympic Committee Hall of Fame. Fans across the nation and around the world remember her as a member of the gold-medal-winning "Magnificent Seven" at the 1996 Atlanta Games, where she also won a bronze medal as she wowed the crowd with her stunning performance in the floor exercise, becoming the first female African-American gymnast to win an individual medal. Dawes is still the only African American gymnast with a gold medal. She also earned a bronze medal with the U.S. team in the 1992 Barcelona Games and made a surprising comeback in the 2000 Sydney Games. Dawes will be receiving an Olympic bronze medal this summer for the team competition in Sydney, due to the new revelations of the Chinese gymnasts being underage. Throughout her career, Dominique has won more National Championship medals than any other athlete, male or female, since 1963, as well as numerous World Championship medals. One of Dominique’s greatest feats came when she swept all four events and won the All Around title at the 1994 National Championships.
States Dominique Dawes on being the spokesperson for the MedPodium product line, "As an athlete focused on health, fitness and wellness, I am excited to assist Cardium in the launch of their new premium skin care product line and new website."
"We welcome Dominique as the spokesperson for our over-the-counter MedPodium product line," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium. "MedPodium represents a new line of foot care products to broaden and complement Cardium's Excellagen topical gel product candidate platform, which is currently subject to a pending FDA 510(k) application submission for U.S. marketing clearance for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, and surgical and trauma wounds. The MedPodium podiatry-focused advanced skin care line expands Cardium's product portfolio beyond the Company's current Excellagen product candidate platform that is being developed as an advanced wound care management device for use by health care professionals. Following our initial product launch, we are planning to broaden our MedPodium line to include aesthetic-based products and other fitness and wellness products."
About MedPodium Advanced Skin Care Product Line
The initial MedPodium podiatric product line, which will carry six products, has been designed to promote foot health and comfort and support preventative care, self examination and early detection of foot ulcers, especially for diabetic patients with lower extremity neuropathy. The MedPodium product line has been formulated to include blended natural and botanical ingredients, and will have no artificial colors and fragrances. The various products contain exfoliants to promote the release of dead skin cells and stimulate the production of new skin cells, natural vitamin antioxidants, natural medicinals to aid in circulation as well as other nutrient-rich ingredients to promote soft and supple skin. Daily use of MedPodium's natural cremes and gels are intended to assist self examination and early detection of foot ulcers, which can potentially become a serious and chronic medical problem that can contribute to increased morbidity and mortality, without proper care and early treatment, especially for diabetic patients.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the U.S. Food and Drug Administration will grant marketing clearance of the ExcellagenXL™ and ExcellagenFX™ product candidates or that we can successfully introduce these or additional products into advanced wound care markets; that Excellagen, Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics™ Generx® and MedPodium™ are trademarks of Cardium Therapeutics, Inc.
Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen™, Excellarate™ and Osteorate™
are trademarks of Tissue Repair Company.
SOURCE Cardium Therapeutics
Discovery Labs Secures $35 Million Committed Equity Financing Facility
Date : 06/14/2010 @ 7:30AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=43213564&symbol=DSCO
WARRINGTON, Pa., June 14, 2010
GLOBE NEWSWIRE
Discovery Laboratories, Inc. (Nasdaq:DSCO), announced today that it has secured a new Committed Equity Financing Facility (2010 CEFF) with Kingsbridge Capital Limited, a private investment group, in which Kingsbridge has committed to provide up to $35 million of capital over a three-year period through the purchase of up to approximately 31.6 million newly-issued shares of Discovery Labs' common stock. Under the terms of the CEFF agreement, Discovery Labs will be able determine the exact timing and amount of any financings, subject to certain conditions and limitations.
The 2010 CEFF represents a source of capital that will allow Discovery Labs, in its sole discretion, to access capital from time to time by requiring Kingsbridge to purchase a specified dollar amount of shares of Discovery Labs' common stock at pre-defined terms. Discovery Labs is not obligated to use any of the $35 million available under the 2010 CEFF. The 2010 CEFF does not restrict Discovery Labs' operating activities and does not prohibit Discovery Labs from entering into or completing debt or equity financings, other than those that would involve certain future-priced securities.
John G. Cooper, Executive Vice President and Chief Financial Officer of Discovery Labs, commented, "This CEFF provides us with an important financing option. The facility provides a competitive cost of capital and flexible structure and should further strengthen our position as we work to resolve the sole remaining issue necessary to potentially gain FDA approval for Surfaxin® for the prevention of respiratory distress syndrome (RDS) in 2011 and advance the development of Surfaxin LS(TM) and Aerosurf®, which we believe hold the promise to significantly advance neonatal respiratory medicine."
In connection with the 2010 CEFF, Discovery Labs issued a warrant to Kingsbridge to purchase up to 1,250,000 shares of common stock at an exercise
price of $0.4459 per share, which represents a 30% premium over the closing price of Discovery Labs' common stock on the date of issuance. The warrant will be exercisable beginning six months from the date of the agreement and will remain exercisable for five years.
The securities issuable in connection with the CEFF, the warrant and the shares issuable upon the exercise of the warrant issued to Kingsbridge have been registered under the Securities Act of 1933 pursuant to a registration statement previously declared effective by the Securities and Exchange Commission and a prospectus, forming a part of the effective registration statement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Capital Market listing requirements prior to the expiration of the additional grace period currently in effect, which could cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
CONTACT: Discovery Laboratories, Inc.
John G. Cooper, EVP and Chief Financial Officer
215-488-9300
Antisoma announces AS1413 and AS1411 presentations at EHA
Date : 06/14/2010 @ 2:01AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43208588&symbol=L%5EASM
London, UK, Cambridge, MA, and Barcelona, Spain: 14 June 2010 - Cancer drug
developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that five
presentations, including an oral presentation, supporting the development of
AS1413 (amonafide L-malate) and AS1411 were presented over the weekend at the
European Hematology Association (EHA) meeting in Barcelona. All are available on
Antisoma's website at http://www.antisoma.com <http://www.antisoma.com/>.
Details of the presentations can be found below.
Enquiries:
Antisoma plc:
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0)7909 915 068
Details of the presentations at EHA
AS1413
#0079 The presence of P-glycoprotein (MDR1) affects the ability of AML patients
to achieve complete remission; results of a meta-analysis of the literature;
Marie et al. (poster)
#0650 Treatment-related AML and AML evolving from MDS: Similar outcomes
following treatment with amonafide + cytarabine; Sekeres et al. (poster)
#0457 The novel DNA intercalator amonafide (AS1413) disrupts the cell cycle by
mechanisms distinct from those of Topo II inhibitors daunorubicin and etoposide;
Senderovich et al. (poster)
AS1411
#1119 Long-term outcomes of responders in a randomized, controlled phase II
trial of aptamer AS1411 in AML; Stuart et al. (oral presentation)
#0643 Gene expression analysis in AML cell line MV4-11 following treatment with
the anti-cancer aptamer AS1411 Senderovich et al. (poster)
About AS1413 (amonafide L-malate)
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the
acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a novel DNA
intercalator that induces apoptotic signalling by blocking topoisomerase II
binding to DNA. This differs from the action of classical topoisomerase II
inhibitors, which induce apoptosis by causing extensive DNA damage. A further
distinctive feature of AS1413 is its ability to evade Pgp and related
transporters responsible for multi-drug resistance (MDR). A pivotal phase III
trial (ACCEDE) is evaluating AS1413 as a treatment for secondary AML, a
condition often associated with MDR and in which outcomes with currently
available treatments are poor. Earlier this month, the US Food and Drug
Administration granted AS1413 Fast Track status for the treatment of secondary
AML.
About AS1411
AS1411 was originally developed by Dr Paula Bates, Dr John Trent and Prof.
Donald Miller at the University of Alabama and later at the University of
Louisville. Antisoma added AS1411 to its pipeline when it acquired the
Louisville-based company Aptamera Inc. in 2005. AS1411 belongs to a new type of
drugs called aptamers. These are short pieces of DNA or RNA that fold into
three-dimensional structures capable of targeting particular proteins. AS1411 is
a DNA aptamer that binds to nucleolin, a protein expressed in the nucleus of all
cells but which in cancer cells is also exposed on the cell surface, providing a
basis for specific targeting by AS1411. When AS1411 binds to nucleolin on cancer
cells, it is internalised and causes apoptosis through interference with various
functions of nucleolin. AS1411 is being evaluated in a phase IIb trial in
patients with relapsed and refractory AML.
About Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company that
develops novel products for the treatment of cancer. The Company has operations
in the UK and the US. Please visitwww.antisoma.com <http://www.antisoma.com/>
for further information about Antisoma.
? maybe tommorow ?!
http://finance.yahoo.com/news/Covidien-to-Present-at-bw-210290507.html?x=0&.v=1
Covidien to Present at Goldman Sachs Healthcare Conference
Covidien (NYSE: COV - News), a leading global provider of healthcare products, will present at the Goldman Sachs 31st Annual Global Healthcare Conference in Los Angeles, CA, on June 17, 2010. Richard J. Meelia, Chairman, President and Chief Executive Officer, will discuss the Company in a presentation scheduled to begin at 11:00AM ET.
A live audio webcast of the presentation can be accessed at Covidien’s Investor Relations website: http://investor.covidien.com. An archived edition of the presentation will be available following the live webcast.